About the role
Specialist Quality Assurance (API) role based on the published job description. Key responsibilities and requirements were extracted directly from the posting for quick review.
BiotechOnsiteQuality
Key Responsibilities
- Responsible for providing oversight and leadership for quality systems execution and operations support, the Specialist Quality Assurance will support manufacturing operations and IPC testing through presence on the floor, and support of complex manufacturing investigations, change control, and unexpected result investigations.
- Main Responsibilities: Provide Quality oversight to plant operations, ensuring appropriate application and execution of GMP compliance
Requirements
- And Amgen Quality Management System in plant operations through phases of commissioning, process qualification, regulatory approval and market supply Support routine GMP documentation review activities (e.g.
- Electronic batch records, SOPs, logbooks, work orders, batch production reports and validation protocols etc.) and ensure key performance indicator met targeted metrics Co-lead and support the deployment of Amgen quality systems, including management review, validation, change control and CAPA and ensure that the systems are managed in compliance with cGMP expectations Participate in complex root cause investigations for deviations Review and approve deviation investigations, change controls, and other quality records (with focus on highly complex records)
- Provides Quality Assurance support in New Product Introduction (NPI) team Coach site Quality Assurance professionals on resolution of complex problems Participate in regulatory inspections, and interact directly with regulatory inspectors Supporting other Quality Assurance initiatives/activities such as continuous improvement projects, supplier quality, stability program, product quality review, customer complaint investigation.
- Win What we expect of you Basic Qualifications: Doctorate degree OR Master's degree and 2 years of directly related experience OR Bachelor's degree and 4 years of directly related experience OR Diploma and 8 years of directly related experience 8 years related work experience (manufacturing, process development, or quality assurance) in the pharmaceutical / biologics industry with progressively increasing responsibility and demonstrated experience in project management, quality assurance, and quality systems.
- Direct experience with bulk manufacturing of biopharmaceuticals/API preferred.
- Demonstrated proficiency of written and verbal communication skills (including technical writing and presentations) with ability to communicate and collaborate effectively with technical and senior management staff.